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NCT01106235 · ClinicalTrials.gov registry record · Phase 1

Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Metastatic Melanoma

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Terminated
Registry status
Phase 1
Development phase
12
Enrollment target

NCT01106235: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT01106235 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01106235, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

RATIONALE: Aldesleukin may stimulate lymphocytes to kill melanoma cells. Treating lymphocytes with interleukin-21 in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin in treating patients with metastatic melanoma

Interventions

  • DRUG cyclophosphamide
  • PROCEDURE biopsy
  • BIOLOGICAL therapeutic autologous lymphocytes
  • BIOLOGICAL aldesleukin

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-04
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

Why NCT01106235 stopped before completion

NCT01106235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.

NCT01106235 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01106235 about?

NCT01106235 is a clinical study titled "Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Metastatic Melanoma". RATIONALE: Aldesleukin may stimulate lymphocytes to kill melanoma cells. Treating lymphocytes with interleukin-21 in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleu...

What is the current status of trial NCT01106235?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-04.

What interventions are being tested in trial NCT01106235?

The interventions under investigation include: cyclophosphamide (DRUG), biopsy (PROCEDURE), therapeutic autologous lymphocytes (BIOLOGICAL), aldesleukin (BIOLOGICAL).

Who is sponsoring clinical trial NCT01106235?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01106235's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01106235, the US trial registry maintained by the National Library of Medicine. NCT01106235 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.